Rotek
Generic Name
Ketorolac Tromethamine
Manufacturer
Incepta Pharmaceuticals
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rotek 30 mg injection | ৳ 50.15 | N/A |
Description
Overview of the medicine
Rotek 30 mg Injection is a non-steroidal anti-inflammatory drug (NSAID) used for the short-term management of moderate to severe acute pain. It provides potent analgesic effects.
Uses & Indications
Dosage
Adults
Initial dose: 30 mg IM or IV as a single dose. Subsequent doses: 15-30 mg IM or IV every 6 hours as needed. Maximum daily dose should not exceed 120 mg/day (IM/IV) or 90 mg/day (oral). Total treatment duration should not exceed 5 days.
Elderly
Lower doses recommended. Initial dose: 15 mg IM or IV as a single dose. Subsequent doses: 15 mg IM or IV every 6 hours. Maximum daily dose should not exceed 60 mg/day.
Renal_impairment
Reduced dosage or contraindication in severe cases (creatinine clearance < 30 mL/min). If used, start with 15 mg every 6 hours, max 60 mg/day. Contraindicated in advanced renal disease.
How to Take
Rotek 30 mg Injection can be administered intramuscularly (IM) or intravenously (IV). For IV administration, it should be given over at least 15 seconds. It is not recommended for intrathecal or epidural administration.
Mechanism of Action
Ketorolac works by inhibiting prostaglandin synthesis through the inhibition of cyclooxygenase (COX-1 and COX-2) enzymes. This reduces the formation of pain and inflammation mediators.
Pharmacokinetics
Onset
Analgesic effect usually starts within 1 hour after administration.
Excretion
Primarily renal (kidneys), with approximately 92% of the dose excreted in urine (60% as unchanged drug, 30% as metabolites). Fecal excretion accounts for about 6%.
Half life
Approximately 4-6 hours in healthy adults; can be prolonged in elderly or renally impaired patients.
Absorption
Rapid and complete absorption after intramuscular (IM) administration. Peak plasma concentrations occur within 30-60 minutes. Bioavailability is nearly 100%.
Metabolism
Primarily hepatic (liver) via hydroxylation and conjugation. The main metabolite is p-hydroxyketorolac.
Side Effects
Contraindications
- Hypersensitivity to ketorolac, aspirin, or other NSAIDs.
- Patients with active peptic ulcer disease, recent gastrointestinal bleeding or perforation, or a history of ulceration/bleeding.
- Moderate to severe renal impairment (creatinine clearance <30 mL/min) or advanced renal disease.
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
- Suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, or incomplete hemostasis.
- Concomitant use with other NSAIDs, aspirin, or pentoxifylline.
- During labor and delivery (due to inhibition of uterine contractions and increased risk of bleeding).
- As prophylactic analgesic before major surgery (due to anti-platelet effect).
Drug Interactions
Lithium
Increased plasma lithium levels and potential for toxicity.
Methotrexate
Increased plasma levels and toxicity of methotrexate.
Pentoxifylline
Increased risk of bleeding.
Corticosteroids
Increased risk of gastrointestinal ulceration or bleeding.
Other NSAIDs and Aspirin
Increased risk of gastrointestinal adverse effects and bleeding.
Diuretics (e.g., Furosemide)
Reduced diuretic and antihypertensive effects.
Anticoagulants (e.g., Warfarin, Heparin)
Increased risk of bleeding, especially gastrointestinal bleeding.
ACE Inhibitors and Angiotensin Receptor Blockers (ARBs)
Reduced antihypertensive effect and increased risk of renal impairment, especially in elderly or volume-depleted patients.
Storage
Store below 25°C (77°F). Protect from light. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose may include abdominal pain, nausea, vomiting, hyperventilation, gastric irritation, and renal dysfunction. Management involves supportive care and symptomatic treatment. There is no specific antidote. Gastric decontamination may be considered if recent oral ingestion.
Pregnancy & Lactation
Pregnancy Category C; Category D in the third trimester or near delivery. Should not be used during pregnancy, especially in the third trimester, due to potential adverse effects on the fetus (e.g., premature closure of ductus arteriosus). It is excreted in breast milk and therefore not recommended during lactation.
Side Effects
Contraindications
- Hypersensitivity to ketorolac, aspirin, or other NSAIDs.
- Patients with active peptic ulcer disease, recent gastrointestinal bleeding or perforation, or a history of ulceration/bleeding.
- Moderate to severe renal impairment (creatinine clearance <30 mL/min) or advanced renal disease.
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
- Suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, or incomplete hemostasis.
- Concomitant use with other NSAIDs, aspirin, or pentoxifylline.
- During labor and delivery (due to inhibition of uterine contractions and increased risk of bleeding).
- As prophylactic analgesic before major surgery (due to anti-platelet effect).
Drug Interactions
Lithium
Increased plasma lithium levels and potential for toxicity.
Methotrexate
Increased plasma levels and toxicity of methotrexate.
Pentoxifylline
Increased risk of bleeding.
Corticosteroids
Increased risk of gastrointestinal ulceration or bleeding.
Other NSAIDs and Aspirin
Increased risk of gastrointestinal adverse effects and bleeding.
Diuretics (e.g., Furosemide)
Reduced diuretic and antihypertensive effects.
Anticoagulants (e.g., Warfarin, Heparin)
Increased risk of bleeding, especially gastrointestinal bleeding.
ACE Inhibitors and Angiotensin Receptor Blockers (ARBs)
Reduced antihypertensive effect and increased risk of renal impairment, especially in elderly or volume-depleted patients.
Storage
Store below 25°C (77°F). Protect from light. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose may include abdominal pain, nausea, vomiting, hyperventilation, gastric irritation, and renal dysfunction. Management involves supportive care and symptomatic treatment. There is no specific antidote. Gastric decontamination may be considered if recent oral ingestion.
Pregnancy & Lactation
Pregnancy Category C; Category D in the third trimester or near delivery. Should not be used during pregnancy, especially in the third trimester, due to potential adverse effects on the fetus (e.g., premature closure of ductus arteriosus). It is excreted in breast milk and therefore not recommended during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Usually 24 to 36 months from the manufacturing date, check specific packaging for exact expiry.
Availability
Hospitals, Clinics, Pharmacies
Approval Status
Approved by FDA/DGDA
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Ketorolac has undergone extensive clinical trials demonstrating its efficacy in acute pain management, particularly post-operative pain, and its non-addictive nature. Studies have also focused on its safety profile and risk factors for adverse events.
Lab Monitoring
- Renal function (serum creatinine, BUN) should be monitored, especially in elderly or renally impaired patients.
- Liver function tests (ALT, AST) if treatment is prolonged or liver dysfunction is suspected.
- Complete Blood Count (CBC) and fecal occult blood tests to monitor for gastrointestinal bleeding, especially with long-term use.
Doctor Notes
- Emphasize the strict short-term use (max 5 days for all routes) due to significant risks of GI, renal, and CV adverse events.
- Carefully assess renal function before and during treatment, especially in elderly or at-risk patients.
- Avoid concomitant use with other NSAIDs, aspirin, or anticoagulants due to increased bleeding risk.
- Monitor for signs of GI bleeding (e.g., black stools, coffee-ground emesis) and educate patients on these symptoms.
Patient Guidelines
- Use Rotek injection strictly for short-term pain relief (not more than 5 days).
- Report any unusual bleeding (e.g., black, tarry stools, blood in vomit), severe stomach pain, swelling, or changes in urine output immediately to your doctor.
- Do not take other NSAIDs or aspirin without consulting your doctor while on Rotek injection.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
Missed Dose Advice
If a dose is missed, take the next scheduled dose as soon as you remember, unless it is almost time for your next dose. Do not double the dose to catch up.
Driving Precautions
Rotek injection may cause dizziness, drowsiness, or visual disturbances. If you experience these effects, avoid driving, operating machinery, or performing tasks that require mental alertness.
Lifestyle Advice
- Avoid or limit alcohol consumption during treatment with Ketorolac, as it may increase the risk of stomach bleeding.
- Maintain adequate hydration, especially if you have risk factors for kidney issues.
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